MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PPICC 5F DL RN; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of 17hb5026 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported to the sales rep that the picc became knotted during placement.The picc was removed.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a knot in the picc was confirmed, and it appeared that the picc was damaged during use.One 30.9cm segment of 5fr d/l powerpicc tubing was returned for investigation.Blood residue was observed within the lumen.The catheter was received with an overhand knot in the tubing.The knot was located between the 42 and 43 cm depth marks and was positioned 5.1cm from the distal tip of the catheter.The knot had been tightened.It was reported that the picc became knotted during placement.The catheter may have inadvertently looped around and through itself within the vessel.No portion of the stylet was contained with the knot.Due to the condition of the returned sample, it was determined that the damage occurred during use.A lot history review (lhr) of 17hb5026 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported to the sales rep that the picc became knotted during placement.The picc was removed.

• Brand Name: DOT PPICC 5F DL RN
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7231354
• Report Number: 3006260740-2018-00067
• Device Sequence Number: 949395
• Product Code: LJS
• UDI-Device Identifier: 00801741141584
• UDI-Public: (01)00801741141584
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CK000754
• Device Lot Number: 17HB5026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1